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Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size.
The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction of the imILT treatment method in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety as well as understanding of the subsequent immunological effects.
This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic cancer will be treated in this trial, which is estimated to be carried out during a time period of 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| imILT | Experimental | Immunostimulating Interstitial Laser Thermotherapy (imILT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunostimulating Interstitial Laser Thermotherapy | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety (adverse events) | Evaluation of adverse events. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory response in circulation measured by quantification of inflammatory cell populations | Quantification of cellular infiltrate and activation markers by flow cytometry. | 36 months |
| Disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut J. Paoli et L. Calmettes (IPC) | Marseille | 13009 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33278792 | Derived | Paiella S, Casetti L, Ewald J, Marchese U, D'Onofrio M, Garnier J, Landoni L, Gilabert M, Manzini G, Esposito A, Secchettin E, Malleo G, Lionetto G, De Pastena M, Bassi C, Delpero JR, Salvia R, Turrini O. Laser Treatment of Pancreatic Cancer with Immunostimulating Interstitial Laser Thermotherapy Protocol: Safety and Feasibility Results From Two Phase 2a Studies. J Surg Res. 2021 Mar;259:1-7. doi: 10.1016/j.jss.2020.10.027. Epub 2020 Dec 2. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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Analysis of the percentage of patients with no new oncological events.
| 36 months |
| Evaluation of Quality of Life (using questionnaires) | Evaluation of Quality of Life is evaluated using standardized questionnaires. | 36 months |
| Usability of the device as evaluated by treatment logs | Evaluation of the laser system by analysis of treatment logs of the device. | 36 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |